GMP Change Control Lead | CAPA & Process Improvement

Scorpion Therapeutics; City of Rensselaer (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Scorpion Therapeutics in the United States, New York area, seeks an experienced Change Control Specialist to drive CAPA-based improvements in manufacturing operations. You will craft change controls, assess proposals, prepare documentation defining scope, impact, risk, and regulatory implications, and lead cross-functional meetings.

The role requires a BS/BA in life sciences or engineering and 0-2+ years (Associate), 2+ years (Specialist), or 5+ years (Senior).

Qualifications

• BS/BA in Life Sciences, Engineering, or related field (or equivalent education and experience).
• Associate Change Control Specialist: 0-2+ years.
• Change Control Specialist: 2+ years.
• Senior Change Control Specialist: 5+ years.
• Level determined based on experience.

Responsibilities

• Craft business plans to advance change control initiatives implementing CAPAs and process improvements supporting manufacturing operations.
• Assess proposed change controls to ensure they meet company standards.
• Coordinate and prepare change control documentation defining scope, impact, risk, and regulatory impact.
• Review, edit, and revise controlled documentation in accordance with cGMP standards.
• Coordinate and/or lead cross-functional meetings to drive implementation.
• Provide advice and mentorship to cross-functional teams for successful, GMP-compliant change controls.
• Independently monitor and progress multiple projects; identify, address, and/or raise obstacles in a timely manner.
• Present business-critical and regulatory-impactful change controls to senior leadership.
• Document training; assist with training new employees.

Skills

Cross-functional collaboration

Regulatory compliance

Change control processes

Mentorship

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Job description

Scorpion Therapeutics in the United States, New York area, seeks an experienced Change Control Specialist to drive CAPA-based improvements in manufacturing operations. You will craft change controls, assess proposals, prepare documentation defining scope, impact, risk, and regulatory implications, and lead cross-functional meetings.

The role requires a BS/BA in life sciences or engineering and 0-2+ years (Associate), 2+ years (Specialist), or 5+ years (Senior).